# K124059: Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)

- Pathway: 510(k) (Traditional)
- Applicant: Lauer Membran Wassertechnik GmbH
- Decided: Mar 25, 2013 after 84 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K811678 (1981). 7 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974899: Gambro Central Water Treatment System CWP 100 - Wro H, Gambro Healthcare (1998) Summary page 1.
- K093608: Gambro Water Purification Unit, Models Wro 300 and Wro 300 H, Gambro Renal Products, Inc. (2010) Summary page 1.
- K032004: Aquaboss Ecoro Dia 50, Lauer Ltd., Hong Kong (2003) Summary page 1.

## Most influential descendants
- K133829: Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2& Aquablus HF (2014), 3 descendants of its own
- K213507: AquaA (2022), 1 descendant of its own
- K252181: AquaA (2025), 0 descendants of its own
- K232953: AquaBplus; AquaB LITE (2024), 0 descendants of its own
- K223479: AQUAbase nX (2023), 0 descendants of its own

## Indications for use
The Aquaboss® EcoRO I, EcoRO I HT, EcoRO Die 11and EcoRO Die 11HT are complete water treatment systems centered around reverse osmosis units of varying output which Include recommended pretreatment components such as carbon filtration, backwash filters, softeners, and temperature blending valves and recommended post treatment such as final filtration intended for hemodialysis applications. The AquabostP water treatment systems are to be used at dialysis clinics or hospitals. The Aquaboss' EcoRO 1,EcaRO I HT, EcoRO Dia 11and EcoRO Die 11HT are intended to remove organic and inorganic substances and microbial contaminants from water. The treated water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple uses and/or to prepare dilute solutions for reprocessing procedures in multiple-use dialyzers. The water treatment systems are designed to meet current AAMI/ISO and Federal (U.S.) standards. The Aquabosso water treatment systems come In the following configurations: (1) EcoRO I: Single-Pass / Single staged: Chemical Disinfection - Catalogue numbers: 1106073- 1109093-1106108 -1106128- 1106143 -1106183- 1106213 - 1106248 - 1106283 - 1106363 Description: Single staged reverse osmosis with permeate capacity of 700 Ith to 3600 Ul. Chemical disinfection possible. Pretreatment of potable water with components such as carbon filtration, backwash filters, softeners, and temperature blending valves. Post-treatment: Ringmain with optional final filtration for distribution of permeate to paint of use. (2) EcoRO 11Twin-Pass / Double Staged Chemical Disinfection Catalogue numbers: 1107073-1107094-1107108- 1101128- 1107143-1107184- 1107214-1107249 -1107283-1107363 Dual/ Double staged reverse osmosis with permeate capacity of 700 I/h to 3600 V/, Chemical Disinfection possible. Pretreatment of potable water with components such as carbon filtration, backwash filters, softeners, and temperature blending valves. Past-treatment: Ringmain with optional final filtration for distribution of permeate to point of use. (3) EcoRO I HT Single-Pass / Single Staged Heat Disinfection Catalogue numbers: 1106072 -1106092 -1106107 -1106127 -1106142 -1106182 -1106212 -1106247- 1106282 -1106362 Description: Single staged reverse osmosis with permeate capacity of 700 I/h to 3600 Vl. Chemical disinfection possible Hot water sanitization with Aquaboss HotRinse SMART 10/ 20/30/40/60. Pretreatment of potable water with components such as carbon filtration, backwash filters, softeners, and temperature blending valves. Post-treatment: Ringmain with optional final filtration for distribution of permeate to point of use. (4) EcoRO 11HT Twin-Pass / Double Staged Chemical Disinfection Catalogue numbers: 1107072 -1107093- 1107107 -1107142 -1107183 -1107213 -1107248 -1107282- 1107362 Description: Dual! Double staged reverse osmosis with permeate capacity of 700 I/h to 3600 Vl. Chemical disinfection possible H-ot water sanitization with AquabossP HotRinse SMART 10/ 20/30/40/60. Pretreatment of potable water with components such as carbon filtration, backwash filters, softeners, and temperature blending valves. Post-treatment: Ringmain with optional final filtration for distribution of permeate to point of use.

Source page: https://510kreport.com/device/K124059
Methodology: https://510kreport.com/methodology